22 results
·
24ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
CUBESCAN / BIOCON-700
FDA 510(k)
FDA Class 2
·Radiology
ADULT DUAL HEATED EVAQUA BREATHING CIRCUIT
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BZE·August 29, 2012
Surgical Instrument
FDA UDI
Jeil Medical Corporation·08800089423880·
MicroSelectron Digital
FDA UDI
Nucletron B.V.·08717213015043·microSelectron Transfer Tube Set for Metal Need...
MABIS
FDA UDI
D-M-S HOLDINGS, INC.·00767056111219·LATEX-FREE LEGACY ANEROID SPHYG W/NYLON CUFF BL...
BD PLASTIPAK¿ SYRINGES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 28, 2023
BD PLASTIPAK¿ SYRINGES
FDA Adverse Event
Malfunction
·BECTON DICKINSON, S.A.·Product code FMF·January 28, 2023
SETx TLIF TAMP
FDA UDI
XENCO MEDICAL LLC·B064XMPH11110211·
DASH HIP
FDA 510(k)
FDA Class 2
·Neurology
LASER 20
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
JDEVOLUTION PLUS
FDA Adverse Event
Injury
·J DENTAL CARE SRL·Product code DZE·August 6, 2025
NEOPUFF INFANT RESUSCITATOR
FDA Adverse Event
Malfunction
·FISHER & PAYKEL HEALTHCARE LTD·Product code BTL·January 15, 2013
UNKNOWN DEPUY ACETABULAR CUP
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·May 14, 2013
AMIS BROACH HANDLE
FDA Adverse Event
Malfunction
·MEDACTA INTERNATIONAL, SA·Product code JDI·May 5, 2011
CARPENTIER-EDWARDS CLASSIC ANNULOPLASTY RING
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code KRH·August 12, 2008
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688N, QTY 100, Microtek Medical, Inc., Columbus, MS 39702.
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
MICROTEK(TM) MEDICAL BUR HOLE LATEX FREE PROBE COVER WITH GEL, featuring IsoSilk(R), 13cm x 244 cm, 5" x 96", REF PC3688, STERILE EO, QTY 20, Microtek Medical, Inc., Columbus, MS 39702
FDA Enforcement
Class II
·Terminated·Ecolab Inc·February 19, 2014
5 x 93 US Probe Cover CMS-6049, Sterile, Single Patient Use. Custom Medical Specialties, Inc., Pine Level, NC, Federal (USA) law restricts this device to the sale by or on the order of a physician. Probe cover
FDA Enforcement
Class II
·Terminated·Custom Medical Specialties, Inc.·February 19, 2014
ARGENT SURGICAL SYSTEMS***BIOPSY Punches*** Disposable manual instrument for skin biopsy.
FDA Enforcement
Class II
·Terminated·Clorox Healthcare Holdings, LLC (dba HealthLink)·July 10, 2013
Durepair Dura Regeneration Matrix: DUREPAIR DURA SUBSTITUTE 2 X 2, 61100; DUREPAIR DURA SUBSTITUTE 3 X 3, 61105; DUREPAIR DURA SUBSTITUTE 1 X 3, 61106; DUREPAIR DURA SUBSTITUTE 4 X 5, 61110; DUREPAIR DURA SUBSTITUTE 1 X 1, 61111; DURA 62100 SUBSTITUTE DUREPAIR 2X2IN NCE, 62100; DURA 62105 SUBSTITUTE DUREPAIR 3X3IN NCE, 62105; DURA 62106 SUBSTITUTE DUREPAIR 1X3IN NCE, 62106; DURA 62110 SUBSTITUTE DUREPAIR 4X5IN NCE, 62110; DURA 62111 SUBSTITUTE DUREPAIR 1X1IN NCE, 62111; DURA 62158 SUBSTITUTE DUREPAIR 5X8IN NCE, 62158.
FDA Enforcement
Class II
·Ongoing·Medtronic Neurosurgery·July 26, 2023